Bioethics has, until now, focused mainly on those who directly
influence human health. It worked to establish guidelines for doctors to
follow when treating their patients, and it provided a backbone for
ethical human research. Bioethics has done a lot of good, but it is time
for the field to branch out to things that affect human health in less
obvious ways. Of the things that bioethics must turn its focus to, one
of the most pressing issues is establishing a duty of care between
pharmaceutical companies and the people they supply.

There has long been a duty of care expected between. doctors and
patients. Doctors are expected to have the knowledge and skills
necessary to perform their job, and they are expected to exercise that
knowledge and skill as well as a reasonably competent professional would
in the same situation. (1) In cases where doctors fail to fulfill this
duty, patients are within their rights to sue for malpractice. But it is
not only doctors who are held to this standard; nurses, dentists, and
therapists can be sued for malpractice as well. What establishes the
"duty of care" is the fact that the individual is in some way
responsible for the well-being of the patient.

If this is the case, then it also seems that pharmaceutical
companies, which provide medicines that are key to human health, could
reasonably be thought to have a duty of care to their consumers. This
duty of care would be a rather unique thing for a company to have. It is
widely held that profit is and should be the most important thing for a
corporation to think of. Most companies, though, are not as directly
responsible for the well-being of their customers as drug companies are.
It is time to work at establishing a mentality that places the good of
the populace over the good of stockholders.

Duties of care do more than provide a guideline for behavior. They
also provide a firm center of responsibility. Health care professionals
are directly responsible for patient well-being, and when they lapse in
that responsibility, they are held responsible for the repercussions
that ensue. This is something that drug companies desperately need.

Marcia Angell, former editor of the New England Journal of
Medicine, once put the basic problem this way: "What does an
eight-hundred-pound gorilla do? Anything he wants." (2) The
pharmaceutical industry is, without a doubt, an eight-hundred-pound
gorilla; drugs are a four-hundred-billion-dollar-a-year industry, and
they are unlikely to become less popular anytime soon. This means that
guiding pharmaceutical companies' behavior is extremely difficult,
and power, proverbially, has corrupted. Of the three commonly discussed
principles of bioethics, pharmaceutical companies routinely violate all
three, often while pretending they don't. This leads to policies
that seem clearly to place profit above people.

Let's start with a discussion of justice. To be entirely fair
to pharmaceutical companies, they donate extensively to developing
nations and have sometimes slashed prices on drugs so that more people
may afford them. Unfortunately, while good definitely comes from
donations, there are often also problems with them. First, drug
companies receive a significant tax cut for donations. Upon the donation
of a drug, the company gains the ability to write off on their taxes the
entire cost of manufacturing the drug and 50 percent of its wholesale
price. (3) This would cause no objections if the companies were
complying with the World Health Organization's guidelines for drug
donations. According to the activist organization Reseau Medicaments et
Developpment, though, companies often donate drugs that are
"inappropriate, outdated, or improperly labeled." (4)
Additionally, ReMeD adds, the drugs are also often about to expire.
Donating these drugs, which would not be marketable in developed
nations, allows the pharmaceutical companies to make a bit of a profit
on drugs that would have otherwise been a complete waste. Far from
aiming to redress imbalances, donating these ineffective drugs actually
shows a lack of regard for the people who receive them.

A second principle of bioethics is beneficence and nonmaleficence,
best described by Hippocrates in Epidemics: "The physician must ...
have two special objects in view with regard to disease, namely, to do
good, or to do no harm." (5) Drug companies would argue that their
research into drugs is a clear instance of doing good, and they love to
extol the virtues of their research, especially in America, where they
attribute high drug prices to the necessity for drug research. What they
do not mention is that from 2000 to 2004, of the 314 drugs approved by
the Food and Drug Administration, only thirty-two were deemed
innovative, and of these, only seven came from one of the top drug
companies. (6) "Innovative" drugs are those that either treat
a previously untreatable sickness or treat it better than the drugs
currently on the market. Where drug companies pour money into research,
then, is on so-called me-too drugs--that is, drugs that are basically
copies of other drugs that have been blockbusters for other companies.
They are rarely tested against and shown to be an improvement over the
competitor's drug because they rarely are. Pharmaceutical companies
seldom invest money in drugs that are not likely to make money. This
means that there is little research going into antibiotics because
antibiotics are unlikely to be used for more than a single round of
treatment. It also means that there is little research into medicines
for diseases prevalent in less developed areas, as these areas are
unlikely to pay the prices that drug companies prefer.

If drug companies cannot be said to be doing good, it becomes
important to examine the other side of the coin, are they doing harm?
The simplest answer is yes. The most obvious example is that of Vioxx.
Merck, which manufactures the drug, was told that it acted "with
wanton disregard for patients taking the drug." (7) Merck kept
Vioxx on the market (and some argue put Vioxx on the market in the first
place) knowing that it increased the likelihood of a heart attack (as
compared to a placebo). More than twenty-seven thousand preventable
heart attacks are estimated to have been caused by the drug. (8)

While I was writing this essay, another perfect example came to
light. GlaxoSmithKline's diabetes drug, Avandia, was linked to a 43
percent increased risk of heart attacks when compared with placebos or
other medicines. (9) Even knowing this, GSK convinced the FDA that the
drug was safe. The FDA ruled that there was insufficient evidence to
warrant removing the drug from the market. It seems clear from this
evidence that drug companies are placing the well-being of their
consumers below that of their bottom line.

Finally, there is autonomy. Pharmaceutical companies would argue
that they encourage autonomy, primarily through direct-to-consumer
advertising, which increases the general public's knowledge of
diseases and how to treat them. (10) The basic premise of the ads is
that consumers will see them and ask their doctors for prescriptions,
and this premise holds true. There are, however, grounds to think that
autonomy is not advanced. The ads vastly overshoot the eighth-grade
reading level recommended for the general public, and they are written
more to guide a decision than to inform it. They overplay the benefits
while minimizing the risks, and fewer than one-third provide alternative
treatment options, even when there are more effective treatments
available. (11) Also, it has long been established that patients have an
ethical and legal right to refuse treatment, but they have neither the
ethical nor the legal right to demand treatment. These advertisements,
though, promote just that.

The image projected by pharmaceutical companies does not square
with the reality, which is that profits are more important than people.
In the coming years, bioethics must combat this reality by establishing
a duty of care for drug companies. If one is in the business of saving
lives, then saving lives, not business, must be the goal.

Remy Miller is an undergraduate at Transylvania University studying
psychology and biology. She currently coordinates a student-run tutoring
program for neighborhood children and after graduation plans to pursue
degrees in medicine and bioethics. She also plans to continue efforts to
bring reform to the pharmaceutical industry.